NLZ

Bur, Ent, Diamond Coated, Single Use, Reprocessed

产品代码

NLZ

器械名称

Bur, Ent, Diamond Coated, Single Use, Reprocessed

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 874.4140

FDA 专业组

Ear, Nose, Throat

上市路径

需提交 510(k) 上市前通告

FDA 分类定义

ENT diamond bur is an accessory to an ENT drill system. It is intended to remove soft and hard tissue during ear, nose and throat surgery. These devices operate at high speed for precise tissue resection. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。